Abscess, Intra-Abdominal | Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
Abscess, Intra-Abdominal research study
What is the primary objective of this study?
The study is contemplating the antibiotic therapy of intraabdominal abscesses. These abscesses are a serious problem in surgical practice. Associated pathophysiologic effects as for example peritonitis may become life threatening or may lead to extended periods of morbidity with prolonged hospitalization. The objective of the sudy is to evaluate whether the combination of Moxifloxacin and Metronidazole is equivalent to Piperacillin / Tazobactam with regard to clinical outcome and eradication of aerobe and anaerobe pathogens in patients with intra-abdominal abscesses.
Who is eligible to participate?
Inclusion Criteria: - Patients who attained full age (18 years) with intra-abdominal abscesses documented by: A) Laparotomy revealing intra-abdominal abscess or macroscopic gastrointestinal perforation OR B) Suspected intra-abdominal abscess and scheduled for operation with at least three of the following criteria: - fever, - leucocytosis, - symptoms referable to the abdominal cavity (nausea, pain), - tenderness with or without rebound / abdominal wall rigidity, - radiological evidence for abscess or gastrointestinal perforation. Exclusion Criteria: - Patients with the following: - indwelling peritoneal catheter, - presumed spontaneous bacterial peritonits, - peripancreatic sepsis or infection secondary to pancreatitis, - peptic or traumatic perforation of gastrointestinal tract of < 24 h duration, - traumatic perforation of the small or large bowel of < 12h duration, - transmural necrosis of the intestine due to acute embolic, thrombotic or obstructive occlusions, - acute cholecystitis, - appendicitis without perforation or abscess, - required open abdomen techniques for management, - gynaecological infection, - known hypersensivity to any of the study drugs, - lifethreatening disease with life expectancy of less than 48 hours, - neutropenia with neutrophil count < 1000 cells/µl, - receiving chronic treatment with imunosuppressant therapy, - HIV-seropositives with CD4 count < 200 cells/µl, - end stage hepatic cirrhosis CHILD PUGH C, - central or peripheral neuropathy, - bradycardia, - symptomatic dysrhythmia in medical history, - syndromes of QTc prolongation or use of concomittant medicaments reported to increase QT interval, - disorder of the electrolyte balance, - previous history of tendinopathy with quinolones, - previously enrolled in the trial or use of any investigational drug within the previous 30 days
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Moxifloxacin/Metronidazole or Piperacillin/TazobactamAntibiotic therapy for patients with intra-abdominal abscesses; Intervention consists of antibiotic treatment of the patients with intraabdominal abscess with either the combination of Moxifloxacin and Metronidazole or Piperacillin/Tazobactam.1. Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered intravenously three times daily.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 1: Moxifloxacin 400 mg, administered intravenously once daily in combination with Metronidazole 500 mg, administered two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once daily and Metronidazole 500 mg twice daily.
2For adult patients with intra-abdominal abscesses matching the criteria to be included will and enrolled in the study arm 2: Piperacillin / Tazobactam 4,5 g administered intravenously three times daily
Start Date: November 15, 2005
Completed Date: August 15, 2011
Phase: Phase 3
Primary Outcome: Clinical success / failure rate at the Test-of-Cure visit
Secondary Outcome: Clinical + Bacteriological response at End-of-Treatment-visit
Study sponsors, principal investigator, and references
Principal Investigator: Michael Winkler, Prof
Lead Sponsor: Hannover Medical School